USFDA APPLICATION NUMBER - 22056 / DOSAGE - FOR SUSPENSION, DELAYED RELEASE;ORAL - EQ 2.5MG BASE/PACKET
Active Ingredient/Active Moiety | ||
Ingredient Name | Basis of Strength | Strength |
---|---|---|
OMEPRAZOLE MAGNESIUM(UNII: 426QFE7XLK) (OMEPRAZOLE - UNII:KG60484QX9) | OMEPRAZOLE | 10mg | 2.5mg | 40mg | 20mg | 10mg |
Inactive Ingredients
Ingredient Name | AstraZeneca Pharmaceuticals LP |
---|---|
ALCOHOL(3K9958V90M) | |
ANHYDROUS CITRIC ACID(XF417D3PSL) | |
ANHYDROUS DEXTROSE(5SL0G7R0OK) | |
ANHYDROUS LACTOSE(3SY5LH9PMK) | |
BUTYL ALCOHOL(8PJ61P6TS3) | |
D&C RED NO. 28(767IP0Y5NH) | |
D&C RED NO. 7(ECW0LZ41X8) | |
D&C YELLOW NO. 10(35SW5USQ3G) | |
FD&C BLUE NO. 1(H3R47K3TBD) | |
FD&C BLUE NO. 2(L06K8R7DQK) | |
FD&C RED NO. 40(WZB9127XOA) | |
FERROSOFERRIC OXIDE(XM0M87F357) | |
GELATIN(2G86QN327L) | |
GLYCERYL MONOSTEARATE(230OU9XXE4) | |
HYDROXYPROPYL CELLULOSE (TYPE H)(RFW2ET671P) | |
HYPROMELLOSES(3NXW29V3WO) | |
MAGNESIUM STEARATE(70097M6I30) | |
MANNITOL(3OWL53L36A) | |
METHACRYLIC ACID(1CS02G8656) | |
POLYSORBATE 80(6OZP39ZG8H) | |
SODIUM HYDROXIDE(55X04QC32I) | |
SODIUM LAURYL SULFATE(368GB5141J) | |
TALC(7SEV7J4R1U) | |
TITANIUM DIOXIDE(15FIX9V2JP) | |
TRIETHYL CITRATE(8Z96QXD6UM) | |
XANTHAN GUM(TTV12P4NEE) |
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